mr. ahmed djoghlaf · beneficial and environmentally sustainable commercialization of genetic...

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May 7, 2009 Mr. Ahmed Djoghlaf Executive Secretary Convention on Biological Diversity 413 St. Jacques Street, 8th Floor Montreal, Quebec Canada H2Y 1N9 Dear Ahmed: Members of the Access and Benefit Sharing Alliance (ABSA) continue to work closely with the International Chamber of Commerce (ICC) and with other industry advocacy organizations in advance of the Technical Experts Group (TEG) on traditional knowledge (TK) associated with genetic resources (GR), scheduled for 16 - 19 June in Hyderabad, India. In response to CBD Notification SCBD/SEL/OJ/VN/GD/66485, issued on 124 February 2009, the ABSA is writing to associate itself with the ICC’s paper: “Traditional knowledge associated with genetic resources: Submission to the CBD ABS Technical Expert Group on Traditional Knowledge Associated with Genetic Resources.” Attached are two additional documents for submission to the TK TEG, including the ICC’s contribution to the Compliance TEG (“Access and Benefit Sharing: Priority Issues for the Compliance TEG; Submission to the Technical Experts Group on Compliance”), and the ABSA ABS Negotiating Principles, both of which are relevant to this meeting. Based on these materials, ABSA Members would like to stress the following key points: ABSA Members remain committed to the timely negotiation of the ABS IR, including elaboration of elements relating to prior informed consent (PIC) and Mutually Agreed Terms (MAT). In absence of PIC and MAT memorialized in a written ABS agreement, ABSA members would not seek to enter the market with a product based on GR with or without associated TK. As noted in the ICC submission to the Compliance TEG, the ABS IR should account for community level procedures and customary legal systems of indigenous and local communities, as needed to ensure legal certainty, clarity and transparency of national ABS systems. Compliance related provisions or principles of local customary law, reduced to written form in the appropriate language, may help to ensure transparency in any individual ABS Agreement. ABSA members also support the conclusions of the Compliance TEG on the need for cost-effective enforcement mechanisms, and believe it is equally important for local and indigenous communities that: “ [a]ny additional measures should be cost-effective; should focus on efforts where there are substantial cases of non-compliance; should not be “one size fits all” in order to be efficient, to maximize the allocation of limited resources; to prevent non-compliance and, ultimately, to avoid disputes.” 1 Some measures, like the establishment of a potentially internationally recognized certificates of compliance, create substantially different commercial risks depending on the use of the associated TK. For example, the plant breeding sector has very different 1 UNEP/CBD/WG-ABS/7/3, 10 February 2009, p.8

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Page 1: Mr. Ahmed Djoghlaf · beneficial and environmentally sustainable commercialization of genetic resources. • An ABS IR should be based on reality and the actual experiences of stakeholders

May 7, 2009

Mr. Ahmed DjoghlafExecutive SecretaryConvention on Biological Diversity413 St. Jacques Street, 8th FloorMontreal, QuebecCanada H2Y 1N9

Dear Ahmed:

Members of the Access and Benefit Sharing Alliance (ABSA) continue to work closely with the International Chamber of Commerce (ICC) and with other industry advocacy organizations in advance of the Technical Experts Group (TEG) on traditional knowledge (TK) associated with genetic resources (GR), scheduled for 16 - 19 June in Hyderabad, India.In response to CBD Notification SCBD/SEL/OJ/VN/GD/66485, issued on 124 February 2009, the ABSA is writing to associate itself with the ICC’s paper: “Traditional knowledge associated with genetic resources: Submission to the CBD ABS Technical Expert Group on Traditional Knowledge Associated with Genetic Resources.” Attached are two additional documents for submission to the TK TEG, including the ICC’s contribution to the Compliance TEG (“Access and Benefit Sharing: Priority Issues for the Compliance TEG; Submission to the Technical Experts Group on Compliance”), and the ABSA ABS Negotiating Principles, both of which are relevant to this meeting. Based on these materials, ABSA Members would like to stress the following key points:

• ABSA Members remain committed to the timely negotiation of the ABS IR, including elaboration of elements relating to prior informed consent (PIC) and Mutually Agreed Terms (MAT). In absence of PIC and MAT memorialized in a written ABS agreement, ABSA members would not seek to enter the market with a product based on GR with or without associated TK.

• As noted in the ICC submission to the Compliance TEG, the ABS IR should account for community level procedures and customary legal systems of indigenous and local communities, as needed to ensure legal certainty, clarity and transparency of national ABS systems. Compliance related provisions or principles of local customary law, reduced to written form in the appropriate language, may help to ensure transparency in any individual ABS Agreement.

• ABSA members also support the conclusions of the Compliance TEG on the need for cost-effective enforcement mechanisms, and believe it is equally important for local and indigenous communities that: “ [a]ny additional measures should be cost-effective; should focus on efforts where there are substantial cases of non-compliance; should not be “one size fits all” in order to be efficient, to maximize the allocation of limited resources; to prevent non-compliance and, ultimately, to avoid disputes.”1

• Some measures, like the establishment of a potentially internationally recognized certificates of compliance, create substantially different commercial risks depending on the use of the associated TK. For example, the plant breeding sector has very different

1 UNEP/CBD/WG-ABS/7/3, 10 February 2009, p.8

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concerns from the industrial enzymes sector.2 Local and indigenous communities may also have particular concerns with respect to certificates of compliance, particularly with respect to cost and other factors cited in the Compliance TEG Report.

• ABSA members support the view expressed by indigenous representatives at the Compliance TEG Meeting n Tokyo that TK databases and registries like India’s TKDL may provide an effective compliance tool to promote PIC and MAT and to avoid future disputes. TK registries and databases add transparency and provide greater opportunities for productive linkages between TK-holders and potential partners.3

• Other Article 15 compliance elements that may also prove effective in support of compliance with Article 8(j) include the requirement for ABS stakeholders to enter into written agreements, and establishment of both national competent authorities and Focal Points as mandatory elements in the ABS IR.4

We hope the foregoing is helpful and look forward to continued discussion at the upcoming TK Experts Meeting, where Dr. Manisha Desai, Eli Lily and Co., will represent ICC Members.

Warm regards,

Susan K. FinstonExecutive Director

Attachments: As specified.

ABSA Submission to CBD/ABS TK TEGp. 2

2 The representation of all industry by one representative has from time to time created difficulties, as was the case at the ABS Experts Group on Certificates. This lack of sector-based business representation hindered timely, meaningful engagement in the development of the recommendations of the group. This may have contributed to continuing questions about their benefits, costs and feasibility, as related in the Compliance TEG Report, Ibid.

3 TK registries and databases can be designed to ensure that TK does not fall into the public domain, by including information on a selective basis, and only with the consent and voluntary participation of indigenous and local communities. Similarly, CBD Contracting Parties can also create so-called “negative lists” of TK related to GR that indigenous and local communities view as sacred or otherwise off-limits for ABS Agreements.

4 As noted at the January 2009 Compliance TEG meeting, CBD Members should consider requiring written documentation of PIC and MAT through the systematic use of contracts between users and providers of genetic resources and associated TK as a mandatory, legally binding element of the ABS IR to ensure transparency, equity and predictability of outcomes for indigenous and local communities and all ABS stake-holders.

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ABS NEGOTIATING PRINCIPLES

INTRODUCTION:

As a core stakeholder in development of any International Regime (IR) relating to Access and Benefit Sharing (ABS), Members of the Access and Benefit Sharing Alliance (ABSA) are committed to identifying practical ABS approaches with demonstrated real-world benefits at the Convention on Biological Diversity’s (CBD) Ninth meeting of the Conference of the Parties (COP 9) in Bonn, Germany.

In this practical approach, we note that a number of prior ABS approaches have fallen short of expected benefits, including policies relating to mandatory disclosure of source, origin and proof of benefit sharing. Equally important, negotiation of the ABS IR should be based on organizational principles that ensure a transparent, equitable, consistent and predictable ABS negotiating process and outcomes.

In that spirit, ABSA Members provide the following principles.

PREAMBLE:

ABSA Members:

• Reaffirm their commitment to respect the sovereign rights of CBD members over their in situ genetic resources (GR) and to the equitable sharing of the commercialization of GR and any related relevant traditional knowledge (TK) derived from indigenous and local communities, assuming a clear, internationally accepted definition of TK.

• Underscore industry’s established track record of compliance with the Bonn Guidelines, including Prior Informed Consent (PIC), Mutually Agreed Terms (MAT) and equitable benefit sharing.

• Support development of comprehensive digital libraries or registries to help identify holders of GR; capacity building to promote best practices for IP management; and the use of model Material Transfer Agreements (MTAs) to ensure effective compliance with PIC and MAT and to provide front-loaded benefits and clarity and fairness in the disposition or sharing of intellectual property rights.

• Believe that there is an increasing recognition among the parties, indigenous communities and NGOs of industry’s critical role as a key stakeholder and generator of commercial benefits from biological diversity.

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PRINCIPLES:

• An ABS International Regime (ABS IR) should include measures that ensure equitable and non-discriminatory terms for access to GR, demonstrably generate benefits, and provide positive incentives to encourage mutually beneficial and environmentally sustainable commercialization of genetic resources.

• An ABS IR should be based on reality and the actual experiences of stakeholders either at the local, regional or state level, including the actual experiences of countries, indigenous communities, NGOs, and industry.

• An ABS IR should recognize the ground realities by which businesses operate so that appropriate incentives are balanced against necessary enforcement provisions for the benefit of all stakeholders.

• To ensure a workable system, all stakeholders (countries, indigenous communities, NGOs and industry) should participate broadly in the elaboration of an ABS IR.

• NGO and industry groups should be encouraged to participate in the elaboration of an ABS IR, regardless of whether their national governments are currently CBD Members.

• Development of ABS elements should reflect the individual needs and experiences of CBD Members at various stages of economic development, which suggests a bottom-up, “cafeteria-style” approach rather than a “top down” one-size-fits-all regime based on a single legally binding instrument.

• An ABS IR should be amenable to simple and expeditious implementation, taking into account the individual needs and experiences of CBD Members.

• An ABS IR should include national regulation and enforcement mechanisms. The Parties, with the participation of stakeholders, should also consider issues of extra-territorial enforcement.

• An ABS IR should ensure transparency, predictability, consistency, durability and non-discriminatory treatment with respect to both access and compliance through the inclusion of clear definitions consistent with the terms and jurisdictional limitations of the CBD itself.

• The CBD ABS WG should continue to rely on such other international organizations as the FAO, WIPO, WTO, as appropriate, for technical input during the 2007-2010 period.

• Supporting work by other international organizations, while essential to the work of the ABS WG, should respect the CBD’s unique mandate and remit for

ABSA ABS Negotiating Principlesp. 2 of 4

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comprehensive ABS negotiations and not prejudge the outcomes of the deliberations of the ABS WG. In this respect, the CBD should continue to rely upon the unique expertise and mandate of WIPO with regard to the harmonization of intellectual property standards.

AREAS OF CONTINUING DISAGREEMENT

• New Additional Mandatory Disclosure Obligations

Patent disclosure obligations enacted by CBD Members have had a documented chilling effect on bioprospecting and GR commercialization. By making patent protection for GR commercialization contingent on an ex post examination of the sufficiency of the disclosure, mandatory patent disclosure regimes place at risk the very basis for the recoupment of investment. [Patent disclosure obligations do not create ABS benefits, are polarizing and drive stakeholders further apart].

• Certificates of Source, Origin and Legal Provenance

ABSA Members do not support the development of a certificate system that would create an additional formality or condition of patentability for biotechnology inventions. They also do not view the CBD Experts Group on Certificates as fully representing the broad spectrum of views found in the biotechnology sector. The group, if reconvened in the future for additional work, should be broadened to reflect the diverse needs and experiences of industry. The CBD Experts Group on Technology Transfer may provide a model for inclusion of more than one industry representative allowing representation of different segments of the biotechnology sector.

• Areas Beyond the Jurisdiction of the Convention

Difficult issues for the ABSA include suggested coverage of both in situ and ex situ resources; pre-CBD vs. post 1994 GR bioprospecting; human vs. plant and animal GR; and products vs. derivatives of GR. Boundary lines should be drawn consistent with the obligations and explicit legal boundaries of the CBD Treaty, as exemplified by the Bonn Guidelines.

All stakeholders require clear boundaries to commit resources to participation in an ABS IR Without a precise understanding of important terms such as "genetic resources, products and/or derivatives," it is impossible for any private company to enter into an agreement with indigenous communities or other holders of traditional knowledge. 

• Lack of Clarity Over the Definition of Traditional Knowledge (TK)

A precise understanding of this important term is also needed before private companies are able to enter into agreements with indigenous communities or other holders of TK. Moreover, if more than one indigenous community (within a country or

ABSA ABS Negotiating Principlesp. 3 of 4

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otherwise) states a claim to the same TK, there needs to be a clear approach to TK rights that does not threaten a private company that has acted in good faith and is working on the basis of PIC and MAT with one of these communities (or with a focal point of a CBD Member that has entered into good faith PIC and MAT with a community). Unless and until further international consensus is reached on the issue of TK, the ABS IR should follow the precedent established by the Bonn Guidelines.

ABSA ABS Negotiating Principlesp. 4 of 4

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Prepared by ICC Commission on Intellectual Property

Access and Benefit Sharing: Priority Issues for the Compliance TEG

Submission to the Technical Experts Group on Compliance

Policy Paper

ICC Document n° 450/1042 – 28 November 2008

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

ICC Document n° 450/1042 – 28 November 2008 1

Access and Benefit Sharing: Priority Issues for the Compliance TEG Submission to the Technical Experts Group on Compliance Business has consistently sought to support development of an Access and Benefit Sharing (ABS) International Regime (IR) that is practical, and provides transparent, predictable and non-discriminatory (i.e. between domestic and foreign actors) processes and outcomes. As reflected by record levels of attendance at the Ninth Conference of the Parties, the business community remains engaged and focused on substantive discussions in the ABS negotiations, including on the objectives, scope and main components of an ABS IR. The ABS IR should include compliance measures with proven effectiveness in the real world, that do not inhibit activities needed to generate benefits from commercial use of Genetic Resources (GR) with or without Traditional Knowledge (TK). This submission to the Technical Experts Group (TEG) on Compliance therefore seeks to identify effective compliance measures, consistent with the encouragement of sustainable, commercial use of GR and related TK in the ABS IR. The business community has been an active participant in negotiations concerning access to and the sharing of benefits from genetic resources even before the entry into force of the Convention on Biological Diversity (CBD) in 1993. The business delegation, coordinated by the International Chamber of Commerce (ICC), today represents various business sectors with diverse interests in genetic resources and related traditional knowledge and their sustainable commercial uses. These include, in alphabetical order: agricultural biotechnology, animal breeding, cosmetics, farming, flavors and fragrances, forestry, herbal medicines and supplements, industrial biotechnology, pets, pharmaceutical and bio-pharmaceutical products, and plant breeding. ICC Members remain committed to the voluntary Bonn Guidelines, which also represent the broad consensus of CBD Members, and include the principles of prior informed consent (PIC) and mutually agreed terms (MAT); in fact the vast majority of business players always try to adhere to laws and regulations. As the ABS IR will affect and regulate the behavior of legitimate players, emphasis overall should be put on creating an enabling environment that will help generate benefits from the sustainable use of GR with or without TK. Based on careful analysis and consideration of real-world experience, an ABS IR which enables and eases legal compliance would have a much greater likelihood of generating sustainable long-term benefits for all ABS stakeholders. It will also be crucial to educate all ABS stakeholders and to provide them with the necessary information on ABS laws to further facilitate compliance. If the IR is to be effective in promoting economic activity, it should maintain and foster the diversity of uses of GR as well as of the commercial arrangements through which they are acquired. ICC believes that it is of key importance that the IR should be a facilitative structure that promotes national ABS regimes that are transparent, non-discriminatory, and predictable. It should not, business believes, become a heavy regulatory framework that would stifle the creation of value from genetic resources, trade and sustainable uses. A highly-targeted and efficient ABS IR will promote the generation of social and economic benefits, and will also support the two other pillars of the CBD: conservation and sustainable use. Some of the international instruments currently under discussion should be considered with caution to avoid overly bureaucratic approaches to ABS that preclude benefit generation. Burdensome measures introduce significant costs for governments, traditional and local communities, research institutions, and business alike. Heavy regulatory burdens may deter larger companies from generating benefits and may price innovative small and medium-sized enterprises out of the market entirely.

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

2 ICC Document n° 450/1042 – 28 November 2008

Most significantly, many of these proposed measures have not been “reality-tested” or subject to a benefit-cost analysis, i.e. proven to create benefits in the real world. With these thoughts in mind, ICC Members offer the following in response to the Terms of Reference for the Technical Experts Group on Compliance: (a) What kind of measures are available, or could be developed, in public and private

international law to: i. Facilitate, with particular consideration to fairness and equity, and taking into

account cost and effectiveness: a. Access to justice, including alternative dispute resolution; b. Access to courts by foreign plaintiffs;

ii. Support mutual recognition and enforcement of judgments across jurisdictions; and

iii. Provide remedies and sanctions in civil, commercial and criminal matters; in order to ensure compliance with national access and benefit-sharing legislation and requirements, including prior informed consent, and mutually agreed terms;

(i) An ABS IR should seek to ensure transparency, predictability, certainty, and non-discriminatory

treatment with respect to compliance measures, including clear definitions consistent with the terms and jurisdictional limitations of the CBD itself. Business, like other stakeholders in the ABS process, seeks transparent, predictable, cost-effective and timely remedies in case of difficulties that may arise in the ABS process.

(ii) If the ABS IR meets these conditions, business is convinced that the great majority of

participants in ABS activities will comply with the ABS IR. Nevertheless business does recognize that serious concerns remain relating to misuse and/or misappropriation of GR, with or without related TK. Therefore business supports a fact-based approach, with agreed parameters and definitions of misuse/misappropriation, to clearly identify the magnitude of the problem within the agreed scope of the International Regime. This would greatly assist in identification, where applicable, of any appropriate and proportionate measures, and contribute to the likelihood of success of the ABS IR overall.

(iii) Business proposes that the ABS IR encourage the systematic use of MTAs, contracts, or

other mutual agreements to the greatest extent possible. These written agreements may include, in addition to the terms and conditions for access and benefit sharing, clauses addressing agreed dispute settlement mechanisms, choice of law, and/or future termination of the agreement, as appropriate.

(iv) Established forms of alternative dispute resolution, including mediation and arbitration, based

on previously agreed written agreements, may provide a cost-effective alternative to cross-border civil litigation given the international scope of arbitral decisions. An example of such an arbitration clause, which cites the Rules of Arbitration of ICC, can be found in Article 8(4)(C) of the sMTA established under the Food and Agriculture Organization (FAO) International Treaty for Plant and Genetic Resources for Food and Agriculture (ITPGRFA). In addition, the New York Convention on the Recognition and Enforcement of Foreign Arbitral Awards (“New York Convention”) is an internationally recognized mechanism for foreign enforcement of arbitral decisions - to which most CBD countries adhere - that can provide effective enforcement in cross-border disputes.

(v) Business also supports voluntary capacity building for resource poor stakeholders in respect

of compliance related matters and is active in these efforts. In particular, ABS stakeholders may find more information and background relating to ICC arbitration services, through educational resources either provided by the ICC International Secretariat or at a national level through local ICC committees, or by other trade associations in collaboration with NGOs and CBD Members.

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

ICC Document n° 450/1042 – 28 November 2008 3

(vi) Business understands the priority that a number of CBD Members place on mutual recognition of and enforcement of judgments across borders to enforce domestic national ABS regimes in cases involving allegations of misuse or misappropriation of GR with or without related TK. At the same time, business notes the historic reluctance of states to enter into multilateral obligations requiring mutual recognition. Business looks forward to a deliberative discussion of this difficult issue so that it can learn more about possible approaches to address legitimate concerns while providing access to justice and due process for all ABS stakeholders.

(vii) Finally, all compliance measures should also be “reality-tested” and subject to a benefit-cost

analysis, i.e. shown in real-world circumstances not to have, on balance, negative implications for the generation and sharing of benefits from sustainable utilization of GR with or without TK.

(b) What kind of voluntary measures are available to enhance compliance of users of foreign genetic resources;

(i) Best practices: Business believes that discussion of existing voluntary guidelines and “best practices” may help to address a broad range of circumstances that arise in the course of ABS agreements between users and providers, including obligations of the parties, mechanisms for sharing results, causes for termination and ways of dispute settlement. ICC Members look forward to providing additional information about such existing guidelines and best practices.

(ii) Guidelines and Codes of Conduct already in place include: the Biotechology Industry

Organization (BIO) Guidelines for BIO Members Engaging in Bioprospecting, EuropaBio Principles for Accessing Genetic Resources, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Guidelines for IFPMA Members on ABS, the BIO Model Material Transfer Agreement (MMTA), and the International Standard for Wild Collection of Medicinal and Aromatic Plants.

(iii) Business also looks forward to discussion of best practices for prior informed consent (PIC),

including guidelines for identification of relevant stakeholders in the negotiation process. Without greater clarity on predictable standards for PIC, business is unable to invest the considerable financial and other resources needed for sustainable commercialization of GR with or without TK. Best practices for PIC, based on a number of existing models and statutes, may provide greater certainty for business while at the same time representing a practical approach to provide guidance for all ABS Stakeholders. (See “Prior Informed Consent and Access and Benefit Sharing: Recognition and Implementation,” DRAFT PAPER, Anne Perrault, Center for International Environmental Law (March 2006) (pp. 16–24 providing PIC-related Procedures, Legislation, Guidelines and Agreements).

(c) Consider how internationally agreed definitions of misappropriation and misuse of GR and

associated TK could support compliance where genetic resources have been accessed or used in circumvention of national legislation or without setting up of mutually agreed terms;

ICC members’ views on an appropriate definition of “misappropriation” will be influenced in large part by the decisions taken by CBD member states on the nature and scope of the ABS IR, decisions which will be taken only after the discussions of the upcoming Compliance TEG. Accordingly, the following is offered as a possible working definition, for discussion purposes, to further greater understanding among delegations in the Working Group process, based to the greatest extent possible on terms, definitions and standards of the CBD:

“Misappropriation of Genetic Resources with or without associated Traditional Knowledge:

Acquiring non-human “Genetic Resources” found in “in situ conditions” - each as defined in Art. 2 of the CBD - in contravention of ABS provisions of a national law pursuant to the International Regime and in force at the time of this acquisition.”

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

4 ICC Document n° 450/1042 – 28 November 2008

(d) How could compliance measures take account of the customary law of indigenous and local communities?

(i) Business has sympathy with the view that the issue of customary law of indigenous and local communities should be addressed by technical and legal experts with expertise in TK issues, ie the TEG on TK. This would minimize the risk that two expert groups would reach different recommendations on the same or similar issues. As noted above, this is an important area where greater clarity from the TK TEG is needed in order for business to give a fuller opinion on possible definitions of “misappropriation” within the ABS IR.

(ii) Taking the foregoing into account, as a general principle business considers that such matters

should be addressed at the national level in light of the vast differences in customary law approaches of different communities in CBD Parties. In this context, the ABS IR should include related provisions only to the extent needed to ensure that legal certainty, clarity and transparency of national ABS systems, including any provisions relating to customary law, are maintained. The ABS IR also should ensure that compliance-related provisions or principles of local customary law - as they relate to any individual ABS Agreement - are reduced to written form in a language understood by all parties to the contract. This would be necessary in order to determine whether these provisions need to be incorporated by reference into the MTA or whether additional clauses are needed, on a case-by-case basis.

(e) Analyse whether particular compliance measures are needed for research with non-

commercial intent, and if so, how these measures could address challenges arising from changes in intent and/or users, particularly considering the challenge arising from a lack of compliance with relevant access and benefit-sharing legislation and/or mutually agreed terms.

(i) At the outset, it is important to recognize that very few collaborative bio-prospecting agreements result in successful products, even in the case of multinational corporations. Successive Merck/INBIO Agreements did not lead to successful commercialization of any of the discoveries found during a complex, multi-year relationship. Nevertheless, the Merck/INBIO agreement, and those that followed, contributed to Costa Rica’s science-base through up-front payments, training and laboratory equipment, and collaborative research, providing substantial and continuing social and economic benefits.

(ii) Business as much as non-commercial research institutes may be deterred by increases in

expenses or bureaucratic “red tape.” Complicated requirements for access and benefit-sharing may have the unintended effect of causing a significant decline in academic and commercial research alike, or, as one commentator noted, may drive scientists underground, resulting in worse documentation of research activities. Declining research may also cause a decline in successful commercialization needed to create social and economic ABS benefits, particularly where outcomes are uncertain and potential commercial benefits lie far in the future.

(iii) This may be especially also true for small and medium enterprises (SMEs), start-up

biotechnology or natural products companies, and certain industry sub-sectors like breeders of ornamental and fruit varieties. For SMEs in particular, it would be essential to find simple rules facilitating access and thus the possibilities to generate sharable benefits. At the same time, business in developing countries may have even a greater share of SMEs – these indigenous entrepreneurs would be particularly disadvantaged by a heavily bureaucratic approach in the ABS IR.

(iv) In reality, it may prove extremely difficult if not impossible to differentiate between ABS

conditions needed to provide incentives for non-commercial and commercial research. Scientific research that starts out as non-commercial may ultimately contribute to the commercial development of a product, either by the same party or by others. Similarly, commercial research may be licensed for public research purposes, as in the case of the

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

ICC Document n° 450/1042 – 28 November 2008 5

development of Golden Rice, which relied heavily on commercially funded research. If a country nonetheless chooses to implement a bifurcated commercial/non-commercial use system, then, it is preferable to spell out the steps needed to convert MAT for non-commercial research into terms for commercial development that protects the interests of all parties, whether applying commercial or non-commercial research, in case of eventual successful commercialization. So it might be another consideration to not draw the distinction between commercial/non-commercial uses but rather distinguish according to the specialties of sectors.

(v) CBD Members clearly have the right to structure their domestic ABS regimes to provide

incentives and approval only for non-commercial ABS activities. CBD Members choosing this option, however, need to be transparent about limiting access to non-commercial ABS activities and, by extension, explicitly recognize that they also are excluding themselves and their right-holders from potential future commercial benefits available to other CBD Members under the ABS IR.

(vi) Commercial and non-commercial ABS stakeholders have varied concerns and interests as

regards publications relating to GR and associated TK. This is an important issue for consideration, particularly given assertions that prohibitions on academic publication rights would have no impact on taxonomic or other non-commercial research. Generally, universities seek open research, with unrestricted publication rights, while business sponsors of research may prefer limited publication rights, at least for an agreed term, in order to protect their proprietary research. This is an area where mutually agreed terms can bridge the gap, meeting individual needs on a case-by-case basis.

* * * * *

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Access and Benefit Sharing: Priority Issues for the Compliance TEG

6 ICC Document n° 450/1042 – 28 November 2008

Annex

Background material relating to arbitration

“Arbitration explained” - Explanatory brief on what arbitration is

“The Institute for Transnational Arbitration Scoreboard of Adherence to Transnational Arbitration Treaties” - Table of countries adhering to transnational arbitration treaties

The FAO International Treaty on Plant Genetic Resources for Food and Agriculture Standard Material Transfer Agreement – see Article 8 on Dispute Settlement (http://www.planttreaty.org/smta_en.htm)

Industry sector guidelines

The Biotechology Industry Organization (BIO) Guidelines for BIO Members Engaging in Bioprospecting (http://www.bio.org/ip/international/200507guide.asp)

The BIO Model Material Transfer Agreement (MMTA) (http://www.bio.org/ip/international/BIO_Model_MTA.pdf)

EuropaBio Principles for Accessing Genetic Resources – (http://www.europabio.org/positions/Bioprospecting%20Principles_Final.pdf)

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Guidelines for IFPMA Members on ABS (http://www.ifpma.org/Issues/CBD)

The International Standard for Wild Collection of Medicinal and Aromatic Plants (http://www.floraweb.de/proxy/floraweb/MAP-pro/Standard_Version1_0pdf)

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ICC Document n° 450/1042 – 28 November 2008 7

The International Chamber of Commerce (ICC) ICC is the world business organization, a representative body that speaks with authority on behalf of enterprises from all sectors in every part of the world. The fundamental mission of ICC is to promote trade and investment across frontiers and help business corporations meet the challenges and opportunities of globalization. Its conviction that trade is a powerful force for peace and prosperity dates from the organization’s origins early in the last century. The small group of far-sighted business leaders who founded ICC called themselves “the merchants of peace”. ICC has three main activities: rules-setting, dispute resolution and policy. Because its member companies and associations are themselves engaged in international business, ICC has unrivalled authority in making rules that govern the conduct of business across borders. Although these rules are voluntary, they are observed in countless thousands of transactions every day and have become part of the fabric of international trade. ICC also provides essential services, foremost among them the ICC International Court of Arbitration, the world’s leading arbitral institution. Another service is the World Chambers Federation, ICC’s worldwide network of chambers of commerce, fostering interaction and exchange of chamber best practice. Business leaders and experts drawn from the ICC membership establish the business stance on broad issues of trade and investment policy as well as on vital technical and sectoral subjects. These include financial services, information technologies, telecommunications, marketing ethics, the environment, transportation, competition law and intellectual property, among others. ICC enjoys a close working relationship with the United Nations and other intergovernmental organizations, including the World Trade Organization and the G8. ICC was founded in 1919. Today it groups hundreds of thousands of member companies and associations from over 130 countries. National committees work with their members to address the concerns of business in their countries and convey to their governments the business views formulated by ICC.